MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN HIP IMPLANT

Catalog Number UNK HIP

Device Problem Failure to Osseointegrate (1863)

Patient Problems Inadequate Osseointegration (2646); No Code Available (3191)

Event Date 11/16/2006

Event Type  Injury  

Manufacturer Narrative

(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Unknown hip implant captures unknown acetabular screw.

Event Description

Literature article entitled, ¿structural femoral head allografts in revision surgery of loosened acetabular cups¿ by c.Wedemeyer, et al, published by the trauma surgeon (2007), vol.110, pp.104-110, was reviewed.The aim of the study was to assess the results after transplantation of allogenic structural femoral heads for the reconstruction of acetabular defects in hip replacement surgery performed between september 1992 and may 1995.In all cases, an allograft structural femoral head was used to fill an acetabular defect.This study involves acetabular cups from a variety of manufacturers.The acetabular cages used in 6 patients were competitor products.The manufacturer of the femoral heads is unknown.This article provides the patient information for all 35 patients.This complaint will capture the 3 patients and associated adverse events implanted with depuy products.The remaining cases provide insufficient information to determine the manufacturer of the acetabular cups used in the acetabular reconstruction and will not be included in the complaint.The authors do not provide information or outcomes for femoral stems.This complaint contains 3 total pcs labeled patient 9, patient 16, and patient 27 in the attached guidance document.Patient 9 is captured in (b)(4).Patient 16 and 27 are linked to parent (b)(4).Female patient implanted with duraloc cup and 4 acetabular screws.Preoperative diagnosis: acetabular paprosky defects 2c.Revised 8 months after index implantation to cemented polyethylene cup.Manufacturer of the cement and cup are unknown.

Manufacturer Narrative

Product complaint # (b)(4).Investigation summary
=
> no device was received.Root cause undetermined.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN HIP IMPLANT
• Type of Device: HIP IMPLANT
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9347304
• MDR Text Key: 185042984
• Report Number: 1818910-2019-117123
• Device Sequence Number: 1
• Product Code: KWA
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK HIP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention